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#POLB Poolbeg Pharma Plc- Capital Markets Day

17 November 2022 – Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, announces that it will be holding a Capital Markets Day for analysts and institutional investors on Wednesday 30 November between 10am – 12:45pm.

 

The event, which will be chaired by Jeremy Skillington, Chief Executive Officer, will provide insights into a number of the Company’s growing pipeline of infectious disease vaccines and treatments and one of its innovative artificial intelligence programmes which is unlocking the power of human challenge trial data. In addition, attendees will gain a greater understanding of how Poolbeg’s unique model and business development strategy can drive growth from the infectious disease market. A networking lunch will follow at the end of the session.

 

There will be an opportunity for attendees to take part in a Q&A with Poolbeg’s management team including Ian O’Connell, Chief Financial Officer and David English, VP of Business Development as well as a number of guest speakers:

 

Dr Tal Almog of CytoReason, one of Poolbeg’s artificial intelligence partners; a world leader in AI which to date has worked with five of the world’s top ten pharma companies

Derek Gilroy, Head of the Centre for Clinical Pharmacology and Professor of Immunology at University College London and has pioneered research examining the molecular and biochemical pathways that regulates the resolution of acute immune reactions

Professor Brendan Buckley, co-founder of Minerva Medical, acquired by IQVIA and Firecrest Clinical, acquired by ICON plc where he held the position of Chief Medical Officer. Brendan has over thirty years of experience in clinical research and has published over 150 scientific papers

Further speakers will be announced in advance of the event

 

Analysts, institutional investors and media are welcome to attend the event in the City of London. Due to restrictions on numbers, it will not be possible for all interested parties to attend in-person. However, a live webcast will be available for retail investors and others to view the presentations here.

 

To register your interest to attend the in-person event, please RSVP to poolbeg@instinctif.com.

 

A recording of the presentation will be made available on the Company’s website after the event here.

Enquiries

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

+44 (0) 207 183 1499

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, Charlie Beeson 
Nigel Birks, Harriet Ward (ECM)

 

+44 (0) 207 220 0500

Singer Capital Markets (Joint Broker)

Phil Davies, Sam Butcher

 

+44 (0) 207 496 3000

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

 

+44 (0) 20 7457 2020

poolbeg@instinctif.com

 

About Poolbeg Pharma

 

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a capital light clinical model which aims to develop multiple products faster and more cost effectively than the conventional biotech model. The Company, headquartered in London, is led by a team with a track record of creation and delivery of shareholder value and aspires to become a “one-stop shop” for Big Pharma seeking mid-stage products to license or acquire.

 

The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025.

 

With its initial assets from hVIVO plc (formerly named Open Orphan plc), an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg has a small molecule immunomodulator for severe influenza (POLB 001) which has commenced its LPS human challenge trial with initial results expected by year end 2022; a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine candidate for Melioidosis (POLB 003). The Company is also developing an oral vaccine delivery platform and is progressing two artificial intelligence (AI) programmes to accelerate the power of its human challenge model data and biobank, with outputs from the first programme expected by year end 2022.

#HVO hVIVO plc- Share Price

hVIVO plc (AIM: HVO) (formerly Open Orphan plc), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, saw the share price rise which was then picked up in the Daily Mail Stock Watch this morning

 

For further information please contact:

 

hVIVO plc

+44 (0) 20 7756 1300

Yamin ‘Mo’ Khan, Chief Executive Officer

Stephen Pinkerton, Chief Financial Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer, Edward Mansfield, Phil Walker, Will King

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell, Niall Gilchrist

Walbrook PR (Financial PR & IR)

Stephanie Cuthbert / Phillip Marriage /
Louis Ashe-Jepson

+44 (0) 20 7933 8780 or hvivo@walbrookpr.com

+44 (0) 7796 794 663 / +44 (0) 7867 984 082 /
+44 (0) 7747 515 393

 

#TEK Tekcapital Plc – Lucyd – Global Licensing Agreement Nautica Brand

Tekcapital Plc (AIM: TEK, OTCQB: TEKCF), the UK intellectual property investment group is pleased to announce Innovative Eyewear, Inc. (“Innovative Eyewear”) (NASDAQ: LUCY; LUCYW), a developer and retailer of cutting-edge smart eyewear and a subsidiary of portfolio company Lucyd Ltd, has licensed the global lifestyle brand Nautica® for smart eyewear.

 

“The Nautica smart eyewear line will stay true to the brand essence of bringing the inspiration of the sea into smart eyewear that is modern and innovative,” says Harrison Gross, CEO of Innovative Eyewear, Inc. “Our Nautica® smart eyewear collection, powered by Lucyd®, will align perfectly with today’s lifestyle, as we believe consumers are looking for designer eyewear that allows them to reman connected to their digital lives.”

 

The Nautica smart eyewear collection is expected to launch for Holiday 2022 or soon thereafter. 

 

About Nautica®

Nautica is a leading global lifestyle brand for men, women, and children, which includes home bedding collections. As a nautical-influenced classic American sportswear brand, we inspire and enable people to experience the joy of water. Nautica is one of the most recognized American brands throughout the world, with over 35 categories available in more than 65 countries with 76 Nautica stores and 291 International stores, and over 1,400 Nautica branded shop in shops worldwide. For more information, please visit https://www.nautica.com/.

 

About Innovative Eyewear, Inc.

Innovative Eyewear is a developer and retailer of smart eyewear, which are designed to allow the users to remain connected to their digital lives, while also offering prescription eyewear and sun protection. The Company believes that traditional frames, no matter how attractive, do not possess the functionality that many eyeglass wearers need and want. Smart eyewear is a multifunctional product that addresses the needs of the optical, hearables and digital assistant markets. We believe that the Company’s products are well positioned in this rapidly growing wearables ecosystem, with the mission to Upgrade Your Eyewear®. For more information, please visit www.lucyd.co .

 

Tekcapital currently owns 100% of the share capital of Lucyd Ltd and 5,189,086 shares (approximately 71%) of its U.S. operating subsidiary, Innovative Eyewear, Inc.  

For further information, please contact:

 

Tekcapital Plc  

Via Flagstaff

Clifford M. Gross, Ph.D. 

SP Angel Corporate Finance LLP

(Nominated Adviser and Broker)

+44 (0) 20 3470 0470  

Richard Morrison/Charlie Bouverat (Corporate Finance)/Abigail Wayne / Rob Rees (Corporate Broking)

 

 

Flagstaff Strategic and Investor Communications

 

+44 (0) 20 7129 1474

Tim Thompson/Andrea Seymour/Fergus Mellon

 

 

About Tekcapital plc

Tekcapital creates value from investing in new, university-developed discoveries that can enhance people’s lives and provides a range of technology transfer services to help organisations evaluate and commercialise new technologies. Tekcapital is quoted on the AIM market of the London Stock Exchange (AIM: symbol TEK) and is headquartered in the UK. For more information, please visit www.tekcapital.com .

 

#ORPH Open Orphan PLC – Director dealings

Open Orphan plc (AIM: ORPH), (to be renamed hVIVO plc (AIM: HVO) effective 26 October 2022), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that it has received notification that on 29 September 2022, Yamin ‘Mo’ Khan, Chief Executive Officer of the Company, purchased 510,204 ordinary shares of 0.1 pence each in the capital of the Company (“Shares”) at a price of 9.8 pence per Share. Following the purchase of shares Mo holds 510,204 ordinary shares representing approximately 0.08 per cent of the Company’s issued ordinary capital.

 

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan plc, said: The purchase of shares in the Company demonstrates both my commitment and my confidence in our long-term growth strategy. Since my appointment as CEO in February 2022, we have made significant progress, delivering continued growth and a record orderbook valued at c.£80m as of 1 September, which provides excellent forward visibility into H2 2022 and 2023.”

 

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

 

For further information please contact:

 

Open Orphan plc

+44 (0) 20 7756 1300

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Stephanie Cuthbert / Phillip Marriage /
Louis Ashe-Jepson

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

+44 (0) 7796 794 663 / +44 (0) 7867 984 082 /
+44 (0) 7747 515 393

#ORPH Open Orphan – Omicron human challenge model

  Vaxart becomes the first client of the programme to test its oral COVID-19 vaccine candidate

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that  hVIVO , a subsidiary of Open Orphan, is developing the world’s first Omicron human challenge model. hVIVO has signed an agreement with Vaxart Inc. (“Vaxart”), (NASDAQ: VXRT) to develop the model with the intent to conduct a subsequent Omicron human challenge study in 2023 to test the efficacy of Vaxart’s oral vaccine candidate, VXA-CoV2-1.

 

To develop the model, hVIVO will manufacture a new SARS-CoV-2 (COVID-19) challenge agent based on the Omicron variant. The Good Manufacturing Practice (“GMP”) compliant virus manufacturing activities will commence immediately and are expected to complete by Q4 2022. Following manufacture of the challenge agent, the Company intends to conduct a characterisation study. Subject to the successful completion of the characterisation study and receipt of relevant regulatory approvals, hVIVO expects to conduct Omicron human challenge studies in 2023.

The characterisation study will establish a dose of the Omicron challenge agent that will cause a safe and reliable infection in healthy volunteers. The study will enrol healthy male and female volunteers who have previously been vaccinated against or infected with SARS-CoV-2, with no known risk factors for severe COVID-19 and low levels of serum neutralising antibodies (and therefore still likely to become infected following inoculation).

hVIVO has two decades of experience and expertise in challenge agent manufacture and clinical characterisation across a range of respiratory viruses including various strains of influenza, respiratory syncytial virus (RSV), human rhinovirus (hRV – common cold virus), as well as the initial circulating SARS-CoV-2 virus and variants which have since emerged. hVIVO leads the Challenge Agent Manufacture Consortium, which has developed international standards that pertain to challenge agent manufacture and storage, to ensure safety, quality and consistency.

Yamin Khan, Chief Executive Officer of Open Orphan, said: “With our leading end-to-end human challenge expertise, we are delighted to be developing the world’s first Omicron human challenge model and to welcome Vaxart as the first client of this programme.

“hVIVO’s fight against the pandemic continues with the development of this new challenge agent. The benefits to Vaxart are immense, and we have already been contacted by a number of biopharma companies looking to test the efficacy of their products using this challenge virus. I have no doubt that the successful completion of the world’s first COVID-19 characterisation, which was published in Nature Medicine earlier this year, has given our customers the confidence to move forward with the less severe yet more infective Omicron challenge model.”

Dr. James Cummings, Chief Medical Officer of Vaxart, said: “A human challenge study of our oral tablet COVID-19 vaccine candidate against the Omicron variant of SARS-CoV-2 is the most rapid and direct way to assess the efficacy of this candidate against a highly prevalent viral strain.

“hVIVO has pioneered COVID-19 characterization and the Omicron human challenge model, and the use of this model in our planned Phase II human challenge trial will rapidly generate robust, controlled data on the ability of our COVID-19 vaccine candidate to prevent infection and the development of symptomatic disease, as well as its effect on viral shedding, which plays a critical role in the spread of infection from one person to another. The results of this study will inform the next steps in the development of our COVID-19 vaccine candidate, which has the potential to transform personal and public health approaches to controlling the global pandemic.”

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “The team and I at hVIVO are excited to begin work to manufacture an Omicron challenge agent, the follow-on characterisation, and future human challenge trials. We have unparalleled expertise in SARS-CoV-2 challenge agent manufacturing, having completed work on both the original Wuhan strain and the subsequent Delta variant, in addition to our prior experience in successfully conducting the world’s first COVID-19 characterisation study, and our decades of experience in conducting human challenge trials. We are delighted to be working with Vaxart on this programme and look forward to the opportunity to subsequently test the efficacy of their exciting novel vaccine.”

Interested in becoming a volunteer?

 

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated  volunteer recruitment website,  www.flucamp.com . By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

 

For further information please contact:

 

Open Orphan plc

+44 (0) 20 7756 1300

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

+44 (0)20 7933 8780 or  openorphan@walbrookpr.com

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /

+44 (0)7747 515393

#ORPH Open Orphan – Board appointment

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces the appointment of Martin Gouldstone as an Independent Non-Executive Director of the Company with effect from 8 June 2022.Martin will also Chair the Audit & Risk Committee and will be a member of the Nominations Committee and the Remuneration Committee.

Martin brings 30 years of corporate development experience in the CRO, healthcare and pharmaceutical sectors, holding a number of senior roles at healthcare AI businesses. Martin has expertise in executing multi-billion dollar deals across Europe and the US, architecting end-to-end portfolio out-sourcing deals, and negotiating multi-year research partnerships.

Martin is currently Global SVP, Business Development at Owkin, a French-American start-up using artificial intelligence to discover and develop better treatments for unmet medical needs. Previously, Martin has held the roles of Chief Business Officer at both BenevolentAI and Sensyne Health and was a Partner at Results Healthcare, an international M&A advisory firm, where he co-led the company’s healthcare practice. Prior to this, Martin was Head of Life Sciences for BDO UK LLP, Senior Director responsible for M&A and joint venture opportunities in Europe for Quintiles (now IQVIA), and Business Development and Licensing Lead at Confirmant Ltd, Pharmacopeia Inc, Sareum Ltd.

Martin holds a BSc in Genetics and has completed a range of post graduate management courses.

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to welcome Martin to the Board of Open Orphan. Martin has extensive corporate development experience in the CRO, healthcare and pharmaceutical sectors and held a number of senior roles in healthcare AI businesses. I look forward to working closely with Martin as we drive further growth across the business.”

Martin Gouldstone, Non-Executive Director, said: “I am delighted to join the Board of Open Orphan at what is an exciting time for the Company and the infectious disease market as it continues to grow significantly post pandemic. I am delighted to bring my previous three decades of experience in the CRO, healthcare and pharmaceutical industry to the Company as it continues to build and expand on partnerships with leading global biopharma companies.”

Regulatory Disclosures

Save for the information set out above and below, there are no further disclosures to be made in accordance with Rule 17, Schedule Two (g) of the AIM Rules for Companies in respect of the appointment of Mr Martin John Gouldstone, aged 55, Martin does not hold an interest in the Company’s share capital.

Current Directorships

Past Directorships

Novara Therapeutics Limited

n.a.

Orthopaedic Research UK

Sempiternum Ltd

For further information please contact:

 

Open Orphan plc

+44 20 7756 1300

Yamin ‘Mo’ Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer / Edward Mansfield / Phil Walker / Will King

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen /

Louis Ashe-Jepson

+44 (0)20 7933 8780 or  openorphan@walbrookpr.com

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /
+44 (0) 7747 515393 

#POLB Poolbeg Pharma – US patents granted for POLB 001 and POLB 002

26 May 2022 – Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, has been granted patents by the US Patent and Trademark Office (USPTO) for POLB 001, a small molecule immunomodulator for the treatment of severe influenza and POLB 002, a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections.

 

POLB 001

The USPTO granted a patent for the majority of Poolbeg’s claims around the use of certain p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment or prevention of severe influenza and the hypercytokinaemia (or “cytokine storm”) it causes through modulation of the immune response (reducing the body’s hyperinflammatory response to the virus). To further strengthen its position, Poolbeg will pursue a continuation patent application to augment the protection offered by this patent family.

 

Poolbeg holds the worldwide rights to POLB 001 for all uses in humans and as such, is exploring the opportunity to expand its IP around this asset to cover new disease areas which would maximise the value of the asset for partnering purposes.

 

POLB 002

The USPTO granted a patent for the identification of defective interfering (DI) RNA-based influenza viruses for use against infection by influenza, that provides a drug candidate with both antiviral prophylactic and therapeutic applications. By having a dual mechanism of action POLB 002 (which was identified using this method) directly interferes with influenza virus replication blocking disease progression and also triggers nasal cells into an antiviral state . In this way, POLB 002 could provide pan-viral protection from respiratory virus infections including influenza, respiratory syncytial virus (RSV), SARS-CoV-2 and others.

 

The Company is continuing working with its patent advisors to broaden and expand the POLB 001 and POLB 002 patent families.

 

Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:

“The additional US patent protection of POLB 001 and POLB 002 is an important step in the commercialisation of these novel infectious disease products. Enhancing the IP protection of these assets across key markets such as the US increases the overall value of these products to potential partners, particularly as we move closer to the commencement of our POLB 001 LPS human challenge trial next month with data expected by year end and monetisation to commence thereafter.”

 

– Ends –

Enquiries

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

 

+44 (0) 207 183 1499

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson
Richard Chambers, Sunila de Silva (ECM)

 

 

+44 (0) 207 220 0500

Arden Partners PLC (Joint Broker)

John Llewellyn-Lloyd, Louisa Waddell

 

 

+44 (0) 207 614 5900

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

 

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

 

+44 (0) 20 7457 2020

poolbeg@instinctif.com

#ORPH Open Orphan – Completion of Nominated Adviser due diligence

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that further to the appointment of Liberum Capital Limited (“Liberum”) as its Nominated Adviser and Joint Broker on 28 April 2022, Liberum has confirmed that is has completed its due diligence .

 

For further information please contact:

 

Open Orphan plc

+44 20 7756 1300

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

  +44 (0) 20 3100 2000

Ben Cryer / Edward Mansfield / Phil Walker / Will King

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen /

Louis Ashe-Jepson

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /
+44 (0) 7747 515393  

#POLB Poolbeg Pharma – TR-1: Notification of major interest in shares

POLB

TR-1: S tandard form for notification of major holdings

 

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii :

Poolbeg Pharma PLC

1b. Please indicate if the issuer is a non-UK issuer   (please mark with an “X” if appropriate)

Non-UK issuer

2. Reason for the notification (please mark the appropriate box or boxes with an “X”)

An acquisition or disposal of voting rights

X

An acquisition or disposal of financial instruments

An event changing the breakdown of voting rights

Other (please specify)iii:

3. Details of person subject to the notification obligation iv

Name

Schroders PLC

City and country of registered office (if applicable)

London , United Kingdom

4. Full name of shareholder(s) (if different from 3.) v

Name

City and country of registered office (if applicable)

5. Date on which the threshold was crossed or reached vi :

18/05/2022

6. Date on which issuer notified (DD/MM/YYYY):

19/05/2022

7. Total positions of person(s) subject to the notification obligation

% of voting rights attached to shares (total of 8. A)

% of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)

Total of both in % (8.A + 8.B)

Total number of voting rights held in issuer vii

Resulting situation on the date on which threshold was crossed or reached

5.128388%

5.128388%

25,641,941.00

Position of previous notification (if

applicable)

Below Reportable Threshold

Below Reportable Threshold

 



 

 

8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rights ix

% of voting rights

Direct

(DTR5.1)

Indirect

(DTR5.2.1)

Direct

(DTR5.1)

Indirect

(DTR5.2.1)

GB00BKPG7Z60

25,641,941.00

5.128388%

SUBTOTAL 8. A

25,641,941.00

5.128388%

B 1: Financial Instruments according to DTR5.3.1R (1) (a)

Type of financial instrument

Expiration
date
 x

Exercise/
Conversion Period
 xi

Number of voting rights that may be acquired if the instrument is

exercised/converted.

% of voting rights

SUBTOTAL 8. B 1

B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b)

Type of financial instrument

Expiration
date
 x

Exercise/
Conversion Period
 xi

Physical or cash

settlement xii

Number of voting rights

% of voting rights

 

SUBTOTAL 8.B.2



9. Information in relation to the person subject to the notification obligation (please mark the

applicable box with an “X”)

Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii

Full chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held starting with the ultimate controlling natural person or legal entity
 xiv (please add additional rows as necessary)

X

Name xv

% of voting rights if it equals or is higher than the notifiable threshold

% of voting rights through financial instruments if it equals or is higher than the notifiable threshold

Total of both if it equals or is higher than the notifiable threshold

Schroders PLC

Schroder Administration Limited

Schroder Wealth Holdings Limited

Schroder & Co. Limited

Schroders PLC

Schroder Administration Limited

Schroder International Holdings Limited

Schroder Investment Management Limited

 

10. In case of proxy voting, please identify:

Name of the proxy holder

The number and % of voting rights held

The date until which the voting rights will be held

11. Additional information xvi

Place of completion

London

Date of completion

19/05/2022

#ORPH Open Orphan – Wellcome publication

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, notes a key considerations document for developing and manufacturing challenge agents published in the Wellcome Open Research Journal co-authored by Alex Mann, Senior Director of Clinical Research of hVIVOand the project lead, a subsidiary of Open Orphan plc, titled ‘Considerations on the Principles of Development and Manufacturing Qualities of Challenge Agents For Use In Human Infection Models’.

The project was funded by the Wellcome Trust and HIC-Vac, an international network of researchers who are developing human infection challenge (HIC) studies to accelerate the development of vaccines, based at Imperial College London. The considerations document was prepared by an hVIVO led consortium, involving engagement with global experts in the human challenge field and manufacturing. It outlines the key aspects of the development, characterisation and manufacture of infectious challenge agents. The aim of the document is to promote volunteer safety whilst maximising access to challenge agents and challenge models in low-income or middle-income countries (LMICs) and academic institutions globally.

It is hoped that these considerations will be used across high-, middle- and low-income countries for the safe production of challenge agents by trained personnel with appropriate facilities, quality control measures and other best practices.

The increase in human challenge studies being established in LMICs and the need for challenge agents to reflect naturally occurring and epidemiologically relevant pathogen strains means there is an increased likelihood that they will be manufactured in conditions where full Good Manufacturing Practice (“GMP”) is not possible. This document fills the previous gap of clear guidance on the minimum requirements for high-quality and safe manufacture outside of GMP facilities.

Challenge agents are the viruses, parasites, bacteria used in human challenge trials that volunteers are purposely challenged with. Depending on the design of the trial, the volunteers may or may not be administered a trial drug candidate before or after being exposed to the challenge agent to provide early proof of concept, allowing the candidate to progress more quickly to phase II or phase III trials.

Wellcome Open Research provides all Wellcome researchers with a place to rapidly publish any results they think are worth sharing. All articles benefit from rapid publication, transparent peer review and editorial guidance on making all source data openly available.

Yamin Khan, Chief Executive Officer of Open Orphan, said:  “As the world leader in conducting human challenge studies I am delighted that Open Orphan continues to play a key role in democratising access to human challenge trials. This latest document provides clear considerations for challenge agent manufacturing, where previously a gap existed regarding the minimum requirements for high-quality safe manufacture outside of GMP facilities. Human challenge trials have clear advantages over traditional clinical field trials, and their global adoption will be vital to progressing the development of vaccines and anti-infectives around the world.”

 

Alex Mann, Project leader and Senior Director, Clinical Science at hVIVO, said: “I was pleased to co-author the considerations document and the associated summary publication in collaboration with the Wellcome Trust and HIC-Vac, that recommends key aspects for researchers to consider for challenge agent development and manufacturing. In recent years, there has been an increase in human challenge studies in low- or middle-income countries where GMP facilities are not readily available. This document will support the development, characterisation and manufacture of challenge agents in these settings, while also maximising volunteer safety and access to challenge agents and challenge models.”

 

Shobana Balasingam, Research Lead in Infectious Disease Prevention at Wellcome, said: “The guidance to manufacture safe and effective challenge agents under GMP conditions differs globally and is not always feasible, which can slow down vital research, particularly in low- and middle-income countries where this research is often most-needed. However, guidelines for manufacturing outside of GMP facilities are not currently available.

 

“As funders of global infectious disease research, Wellcome are please to support this clear and practical document for developing challenge agents where GMP is not possible. This guidance can ensure the full potential of human infection studies around the world, which provide crucial insight into infectious diseases, helping to rapidly accelerate the development of vaccines.”

 

An editorial will be published alongside the report: ‘Considerations on the Principles of Development and Manufacturing Qualities of Challenge Agents For Use In Human Infection Models’ by Shobana Balasingam, Sarah Meillon, Cecilia Chui, Alex Mann, Carine La, Charlie Weller, Debbie King and Emma Smith. Available in Wellcome Open Research. DOI: https://doi.org/10.12688/wellcomeopenres.17869.1

 

Interested in becoming a volunteer?

 

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated  volunteer recruitment website,  www.flucamp.com . By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

 

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

 

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

 

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

 

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

+44 (0)20 7933 8780 or  openorphan@walbrookpr.com

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /

+44 (0)7747 515393

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